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Pharvaris N.V. (PHVS) is a pioneering, clinical-stage biopharmaceutical company dedicated to developing novel, oral bradykinin B2 receptor antagonists for the treatment and prevention of hereditary angioedema (HAE) and other related conditions. With a strategic focus on unmet medical needs in rare diseases, Pharvaris aims to provide safer, more effective, and easier-to-administer alternatives to currently available injectable therapies.
Core Business and Expertise
Pharvaris is spearheaded by a team with profound expertise in HAE, including the discovery and approval of the HAE treatment icatibant. The company leverages this foundation to develop small, potent molecules targeting the bradykinin B2 receptor—a clinically validated therapeutic target. By inhibiting bradykinin signaling at this receptor, Pharvaris' lead candidate, deucrictibant, offers potential for both acute and prophylactic treatment of HAE and other bradykinin-mediated diseases.
Current Projects and Achievements
- Pharvaris has made significant progress in its clinical development programs. Notably, the U.S. FDA has lifted the clinical hold on deucrictibant, allowing the continuation of global development, including Phase 2 and Phase 3 trials.
- The company's Phase 2 CHAPTER-1 study demonstrated positive top-line data for deucrictibant in preventing HAE attacks, with significant reductions in attack rates at both 20 mg/day and 40 mg/day doses.
- Deucrictibant is being developed in two formulations: a rapid-onset capsule for acute treatment and an extended-release tablet for long-term prophylaxis.
Future Outlook
Pharvaris is preparing for the global Phase 3 CHAPTER-3 study and continues to engage with regulatory authorities to align on study designs. The company is also expanding its research into other bradykinin-mediated conditions, aiming to broaden its therapeutic portfolio.
Financial Condition and Market Presence
Strong financial performance and strategic investor support underscore Pharvaris’ potential. The company’s financial health allows it to fund ongoing and future clinical trials while building infrastructure for the anticipated launch of deucrictibant. Pharvaris is committed to operating transparently, with regular updates provided to its stakeholders through its website and regulatory filings.
With a clear mission to transform the treatment landscape for rare diseases, Pharvaris stands out for its innovative approach and dedication to improving patient outcomes.
Pharvaris reported Q3 2024 financial results and business updates. The company maintains a strong financial position with €305 million in cash. R&D expenses increased to €25.8 million from €18.5 million YoY, while G&A expenses rose to €12.1 million from €7.7 million. Net loss widened to €41.7 million (€0.77 per share) from €23.6 million (€0.58 per share) YoY.
The company plans to initiate CHAPTER-3, a Phase 3 study for deucrictibant in HAE prophylaxis by year-end 2024. Long-term extension data showed 93% reduction in attacks for prophylaxis and median symptom relief onset of ~1.1 hours for on-demand treatment.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks, has announced its participation in the Inaugural Guggenheim Securities Healthcare Innovation Conference. The event will take place at the InterContinental Boston from November 11-13, 2024.
The company will participate in a fireside chat on Wednesday, November 13, at 9:30 a.m. ET. A live audio webcast will be available on the Investors section of the Pharvaris website, with the replay accessible for 30 days after the presentation.
Pharvaris (Nasdaq: PHVS) presented seven posters at the 2024 ACAAI Annual Scientific Meeting, showcasing data supporting deucrictibant's development for hereditary angioedema (HAE). The CHAPTER-1 Phase 2 clinical trial demonstrated deucrictibant's efficacy in reducing HAE attack symptoms to 1.7% (40 mg/day) from 14.6% (placebo). The ongoing open-label extension study showed approximately 80% of participants achieved at least a 90% reduction in attack rate. Non-clinical data from bradykinin challenge models in non-human primates supported the drug's pharmacokinetic and pharmacodynamic profile, validating the dosing strategies for both prophylactic and on-demand treatment of HAE attacks.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company, announced the acceptance of multiple abstracts for presentation at upcoming scientific meetings. The presentations will focus on deucrictibant, an oral bradykinin B2 receptor antagonist for treating hereditary angioedema (HAE) attacks.
Key events include:
- Seven e-Poster presentations at the American College of Allergy, Asthma, & Immunology's Annual Scientific Meeting in Boston, October 24-28, 2024
- Three poster presentations at the Canadian Society of Allergy and Clinical Immunology in Banff, Alberta, November 6-9, 2024
- One oral presentation at the Japanese Society of Allergology in Kyoto, October 18-20, 2024
The presentations will cover various aspects of deucrictibant, including long-term safety and efficacy, biomarker assays, and results from clinical trials such as CHAPTER-1 and RAPIDe-2.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE) attacks, will host a virtual investor event on October 23, 2024, at 10:00 a.m. ET/16:00 CET. The event will focus on:
- Unmet needs in prophylactic and on-demand HAE attack treatment
- Potential of deucrictibant to address these needs
- Current HAE market dynamics
Presenters include medical experts Dr. Michael E. Manning and Dr. Raffi Tachdjian, along with Pharvaris executives Berndt Modig (CEO), Dr. Peng Lu (CMO), and Dr. Wim Souverijns (CCO). A live Q&A session will follow the presentations, and an archived replay will be available for at least 30 days after the event.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company, announced the acceptance of six abstracts for presentation at the 2024 Global Angioedema Forum – HAEi Global Leadership Workshop in Copenhagen. The presentations focus on deucrictibant, an oral bradykinin B2 receptor antagonist for treating hereditary angioedema (HAE) attacks. Two oral presentations and four poster presentations will cover topics including:
1. Long-term safety and efficacy of deucrictibant for HAE prophylaxis
2. Long-term efficacy and safety in treating HAE attacks
3. Results from the CHAPTER-1 Phase 2 trial
4. Impact on health-related quality of life
5. Comparison with standard of care treatments
6. Design of the RAPIDe-3 Phase 3 trial
Presentation materials will be available on the Pharvaris website. The company will also make a donation to the Marcus Maurer Fellowship Program through GA2LEN in memory of Prof. Marcus Maurer.
Pharvaris (Nasdaq: PHVS) announced key updates for its lead compound deucrictibant in hereditary angioedema (HAE) and acquired angioedema (AAE-C1INH) treatment:
1. CHAPTER-3, a global Phase 3 study of deucrictibant extended-release tablets for HAE prophylaxis, is set to begin by year-end 2024.
2. The company plans to expand clinical development into AAE-C1INH following promising investigator-initiated trial results.
3. Long-term extension data from ongoing studies (CHAPTER-1 part 2 and RAPIDe-2) demonstrate sustained efficacy and tolerability in both prophylactic and on-demand HAE treatment.
4. Pharvaris will present additional clinical, real-world, and nonclinical data at the 2024 Bradykinin Symposium, highlighting deucrictibant's differentiated profile.
Pharvaris (Nasdaq: PHVS) presented long-term extension data for deucrictibant in the treatment of hereditary angioedema (HAE) at the Bradykinin Symposium 2024. Key findings include:
1. Prophylactic treatment: 93% reduction in attack rate compared to baseline, with a median attack rate of zero per month and 99% attack-free days after over a year of treatment.
2. On-demand treatment: Median onset of symptom relief in 1.1 hours, with 85.8% of attacks resolving completely within 24 hours.
3. Safety profile: Deucrictibant was well-tolerated with no new safety signals observed in both prophylactic and on-demand settings.
These results support deucrictibant's potential as a preferred therapy for HAE management, demonstrating efficacy in both prophylactic and on-demand treatments.
Pharvaris (Nasdaq: PHVS) presented data at the 7th Bradykinin Symposium, showcasing the potential of deucrictibant for treating hereditary angioedema (HAE). Key findings include:
1. Long-term safety and efficacy of deucrictibant for HAE prophylaxis, with a median attack rate of zero for over a year.
2. Rapid onset of symptom relief (median 1.1 hours) in treating HAE attacks.
3. Improvements in disease control and quality of life for HAE patients.
4. Favorable comparison to standard of care in a propensity score-matched analysis.
5. No evident effects on cardiac parameters in nonclinical and clinical studies.
6. Development of new biomarker assays for bradykinin-mediated disorders.
These results support the further development of deucrictibant as a potential oral therapy for HAE prevention and treatment.
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists for hereditary angioedema (HAE), announced the acceptance of 12 abstracts for presentation at the 7th Bradykinin Symposium in Berlin, Germany, from September 5-6, 2024. The presentations include two oral presentations and ten poster presentations covering various aspects of their lead compound, deucrictibant.
The presentations will showcase clinical, real-world, nonclinical, and discovery data on deucrictibant, including its efficacy in HAE prophylaxis, treatment of HAE attacks, long-term safety, and cardiovascular safety. The symposium will also feature presentations on novel biomarker assays and preclinical models for bradykinin-mediated disorders.
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